# K231354: Pocket Ultrasound System (C10)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Konted Medical Technology Co.,Ltd
- Decided: Dec 20, 2023 after 224 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 174 ancestors in all.
2 later devices descend from it; 1 cites it directly.
6 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162549: Lumify Ultrasound System, Philips Health Care (2016) Summary page 6.

## Most influential descendants
- K241979: Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) (2024), 1 descendant of its own
- K261081: Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (2026), 0 descendants of its own

## Indications for use
The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes: Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo. The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K231354
Methodology: https://510kreport.com/methodology